AFDO RAPS Healthcare Products Collaborative
Sathe, Alison



Senior Vice President, Data Strategy & Analytics

Redica Systems

Alison Sathe is the Senior Vice President of Data Strategy & Analytics at Redica Systems, where she leads the company’s data and analytics initiatives including AI applications. With a background in biomedical engineering and 20+ years experience, Alison has held executive roles at both startups and established medtech companies overseeing Regulatory and Quality Affairs. Her experience includes early FDA interactions, regulatory submissions, securing FDA clearance/approval, and proactive compliance initiatives. An entrepreneur at heart, Alison founded ClearMark, an electronic Quality Management System (QMS) software platform tailored for medical device companies, and Regulatory Mark, a regulatory consulting firm.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.


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